RecruitingNot ApplicableNCT05448365

Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid

The Use of Vitamin D in Combination With Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in the Treatment of Women With Uterine Fibroid

Sponsor

Lo.Li.Pharma s.r.l

Enrollment

60 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Vitamin D Epigallocatechin Gallate Uterine Fibroids D-chiro-inositol Inositol Vitamin B6

Summary

The study will evaluate the impact on uterine fibroids' volume of a combination of natural molecules including Epigallocatechin gallate, Vitamin D, D-chiro-inositol and Vitamin B6. The patients will be evaluated at baseline and after three months of treatment with placebo or product.

Eligibility

Sex: FEMALEMin Age: 30 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of natural supplements — vitamin D, EGCG (a green tea extract), D-chiro-inositol, and vitamin B6 — to see if they can help reduce the size of uterine fibroids (non-cancerous growths in the uterus) and ease symptoms before surgery. **You may be eligible if...** - You have been diagnosed with uterine fibroids (at least one fibroid 4 cm or larger, or multiple fibroids) - You are scheduled to have surgery for your fibroids - You have symptoms such as heavy or irregular periods or pelvic pain **You may NOT be eligible if...** - Your BMI is above 30 (obese) - You are currently pregnant or breastfeeding - You have diabetes - There is a suspicion of cancer in the uterus - You have a known cancer diagnosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTEpigallocatechin gallate, Vitamin D, Vitamin B6, D-chiro-inositol

The patients will take for three months two tablets per day each containing 150mg epigallocatechin gallate, 25 mg D-chiro-inositol, 5mg Vitamin B6 and 25μg Vitamin D

DIETARY_SUPPLEMENTPlacebo

Maltodextrines